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FDA 510(k)

EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)

K-Number: K234090 · 2024-03-20

ApplicantSurgvision GmbH
Decision Date2024-03-20
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004) is a medical device manufactured by Surgvision GmbH. It received FDA 510(k) clearance on 2024-03-20 under approval number K234090. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)?

EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004) is a medical device that received FDA 510(k) clearance on 2024-03-20. It is manufactured by Surgvision GmbH. The 510(k) number is K234090.

When was EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004) approved by the FDA?

EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004) received FDA 510(k) clearance on 2024-03-20, under approval number K234090.

What company makes EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)?

EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004) is manufactured by Surgvision GmbH.

What is the FDA product code for EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)?

The FDA product code for EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004) is IZI.

Other Devices by Surgvision GmbH

K214097Explorer Air II K222240EXPLORER AIR® II

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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